Therapeutic methods and delivery systems utilizing sex steroid precursors

Abstract

Sex steroid precursors such as dehydroepiandrosterone and dehydroepiandrosterone sulphate, and compounds converted in vivo to either of the foregoing, are utilized for the treatment of vaginal atrophy, hypogonadism, diminished libido, loss of collagen or connective tissues in the skin, and, in combination with an estrogen and/or progestin, for the treatment of menopause. The precursors may be formulated for percutaneous or transmucosal administration. Gels, solutions, lotions, creams, ointments and transdermal patches for the administration of these precursors are provided, as are certain pharmaceutical compositions and kits which can be used for the prevention and treatment of a wide variety of conditions related to decreased secretion of sex steroid precursors by the adrenals.

Claims

1. A pharmaceutical composition in the form of a transdermal or percutaneous cream, ointment, or lotion, said pharmaceutical composition comprising a carrier having dissolved therein at least one sex steroid precursor selected from the group consisting of dehydroepiandrosterone, dehydroepiandrosterone sulphate, and compounds converted in vivo to either of the foregoing, said precursor being present at a concentration of at least 7% by weight relative to the total pharmaceutical composition suitable for achieving and maintaining a serum level concentration 4 to 13 micrograms per liter, and said carrier being compatible with skin or mucosa and allowing penetration of said precursor through said skin or mucosa, said carrier having sufficient viscosity to maintain said precursor on a localized area of skin or mucosa, without running or evaporating, for a time period sufficient to permit substantial penetration of said precursor through said localized area of said skin or mucosa.

2. The pharmaceutical composition of claim 1 wherein said carrier includes a mixture of a pharmaceutically acceptable solvent and at least one thickening agent.

3. The pharmaceutical composition of claim 2 wherein said carrier includes a mixture of organic and inorganic solvents.

4. The pharmaceutical composition of claim 3 wherein said carrier includes water and alcohol.

5. The pharmaceutical composition of claim 4 wherein said precursor is DHEA.

6. The pharmaceutical composition of claim 4 wherein said precursor is DHEA-S.